NCT07609108ClinicalTrials.gov

Pridopidine Phase 3 Study in Huntington's Disease

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Huntington's Disease (HD)

RecruitingTaking participants now, according to the registry record.

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In brief

Phase 3400 participants sought66 sites12 countries

Registered in 1 registry

ClinicalTrials.govNCT07609108Open this record at ClinicalTrials.govSynced 2 days ago

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Trial information is shown as published by the registry, in its original language.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

Present: Registered before enrolment beganFirst posted 2026-05-27; recorded start 2026-07-01
Present: Has a defined primary outcomeA primary outcome measure is listed in the record
Present: The primary outcome states a time frameThe primary outcome measure records a time frame
Present: Participants are randomly assignedAllocation is recorded as randomised
Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
Present: Uses blinding (masking)A masking level is recorded in the record
Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
Present: Sponsor has 2 other studies in this databaseCounted from the lead sponsor named in the record (Prilenia)
Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database

The record lists 1 condition.
Lead sponsor type recorded as: industry.
Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourSTRONG

A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.

How this score is built

Randomised allocation20/20
Participants are randomly allocated between arms
Blinding20/20
Quadruple-blind
Control arm13/15
Placebo / sham control arm
Primary-outcome specificity10/10
Named primary outcome with a defined time frame
Endpoint type3/10
Surrogate or intermediate endpoint (conservative default)
Multi-centre0/8
Single site, or site count not stated
Data monitoring committee7/7
A data monitoring committee is in place
Prospective registration5/5
Registered before the study start date
Protocol / SAP posted0/5
No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study, international in scope: 400 participants (target), run at 66 sites, across 12 countries.

How this score is built

Enrolment25/40
400 participants (target)
Site count0/25
Site count not stated in the record
Country count0/15
Country count not stated in the record
Planned duration9/10
Planned over about 49 months
Sponsor scale1/10
Prilenia has led 3 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built

Investigator standing0/100
No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Summary

The goal of this clinical trial is to learn if pridopidine can slow the clinical decline of Huntington's Disease (HD) in adult participants. It will also inform about the safety of pridopidine. The main questions the study aims to answer are: Does pridopidine slow the overall worsening of HD over 1 year? Does pridopidine slow the worsening of specific aspects of HD over 1 year, namely the clinical progression, the ability to perform daily life activities (functional capacity), the mind's ability to process information (cognition), working of the muscles (motor function), and quality of life? Researchers will compare the drug pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works better than placebo to treat HD. During the first year of the study, participants will have the same chance to receive either pridopidine or placebo. Participants will: Take 1 pridopidine or placebo capsule twice daily for 12 months. Visit the clinic 6 times within 1 year for checkups and tests. All participants who complete this 1-year placebo-controlled study period will roll over into an additional 2-year study period during which all participants will receive pridopidine treatment, including participants who had received placebo during the first year. During this additional 2-year treatment period participants will visit the clinic a total of 6 times for checkups and tests.

This Phase 3 study consists of two study periods, a randomized, double-blind, placebo-controlled 1-year study period and a 2-year open-label extension (OLE) period. The study assesses the effect of pridopidine 45 mg twice daily on HD in participants who are not using antidopaminergic medications (ADMs) at study start. Main objectives of the study will be to assess the effect of pridopidine on clinical progression of HD within 1 year and to evaluate the effect of pridopidine on functional capacity, cognition, motor function, quality of life (QoL), and speech in participants with HD within 1 year. The target population in this study are adult participants (age 23-65, inclusive) with adult-onset HD (onset of signs and symptoms and a diagnosis ≥21 years of age). Eligible participants have not been using ADMs for at least 6 months prior to the screening visit. In case ADM treatment is deemed necessary by the treating physician during the study, specific ADMs and doses may be initiated. Female participants who are pregnant, planning to become pregnant or breastfeeding are not allowed to enter the study. The treatment period will start with a 2-week titration period of once-daily treatment (1 capsule of pridopidine or placebo taken orally in the morning). From Day 15 onwards, all participants will take the study drug twice daily: in the morning and in the afternoon. Treatment will continue for an additional 50 weeks. The placebo-controlled study period includes 6 in-clinic visits and 5 telephone visits (safety calls) during the 1-year treatment period. The placebo-controlled study period will be followed by a 2-year OLE period. During the OLE period, all eligible participants will receive pridopidine. The OLE will consist of a 2-year treatment period, including an initial 2-week (re)titration period for all participants at pridopidine once daily and a maintenance period of 102 weeks with pridopidine twice daily. The blinding of the original treatment assignment will be maintained for all participants and study personnel during the OLE period. A total of 6 in-clinic visits and 6 telephone visits (safety calls) are planned during the 2-year OLE period.

Conditions

Huntington Disease

Eligibility

Eligibility
Sex	All
Ages	23 Years – 65 Years
Healthy volunteers	No

Eligibility as written in the registry

Inclusion Criteria: * Adult-onset HD (onset of signs and symptoms and a clinical diagnosis at ≥21 years of age). * A diagnosis based on clinical features and the presence of ≥40 CAG repeats in the huntingtin (HTT) gene confirmed by historical laboratory quanitified results or by a diagnostic test at Screening. * Diagnostic confidence level (DCL) of 4 (DCL=4 unequivocal motor signs, ≥99% confidence) on the standardized motor exam Total Motor Score (TMS). * Total Functional Capacity (TFC) score of ≥7 at Screening and Baseline. * Cytosine-Adenine-Guanine (CAG)-Age Product (CAP)100 score ≥95 at Screening. * Independence Scale (IS) score ≤90% at Screening. * Total Motor Score (TMS) of ≥20 at Screening and Baseline. * Not using ADMs (VMAT2i and neuroleptics/antipsychotics) for at least 6 months prior to Screening visit. Importantly, it is not encouraged to discontinue the participants' ADM treatment solely for enrollment in the current trial. Exclusion Criteria: * Clinically significant cardiovascular disease (e.g. QTcF \>450 msec \[males\] or \>470 msec \[females\], arrhythmias, uncontrolled atrial fibrillation, or congenital long QT syndrome), seizure history ≤5 years, significant neurological disorders (e.g. intracranial pathology or cerebrovascular events), active/recent malignancy (unless localized and resolved), or any serious or uncontrolled systemic disease (e.g. hepatic, renal, respiratory, endocrine, infectious \[HBV, HCV, HIV\], or psychiatric) that may pose safety risk or interfere with participation. * Severe hepatic or renal impairment. * Any mutant huntingtin (mHTT) lowering therapy in the past year. * Medications that prolong QT interval, taken within 4 weeks of the baseline visit. * Use of pridopidine within 6 weeks or 5 half-lives before the screening visit. * Previous participation in intracranial gene therapy study. * Laboratory values that fall outside of the central laboratory's reference range at Screening and are considered clinically significantly abnormal by the Investigator and affect the participant's suitability to participate in the study or put the participant at risk if he/she enters the study in the Investigator's opinion. * Female participants who are pregnant, planning to become pregnant or breastfeeding.

Eligibility in plain statements

This record's criteria have not been broken into separate statements yet. The registry text above is complete and is the authoritative version.

Study design

Study design
Study type	Interventional
Phase	Phase 3
Allocation	Randomised
Intervention model	PARALLEL
Primary purpose	TREATMENT
Masking	QUADRUPLE (4)
Enrolment	400 participants sought

Sponsor and collaborators

Prilenia Sponsor
Ferrer Internacional S.A. Collaborators

Arms and interventions

PridopidineEXPERIMENTAL
During the titration period (2 weeks), pridopidine 45 mg capsules will be taken orally once daily (in the morning) for 2 weeks. Afterwards, pridopidine 45 mg capsules will be taken orally twice daily (in the morning and in the afternoon; 7-10 hours apart) for 50 weeks.
PlaceboPLACEBO_COMPARATOR
During the titration period (2 weeks), matched placebo hard gelatin capsules will be taken once daily (in the morning) for 2 weeks. Afterwards, placebo capsules will be taken twice daily (in the morning and in the afternoon; 7-10 hours apart) for 50 weeks.

Interventions

Drug Placebo
Matched placebo hard gelatin capsule
Drug Pridopidine
Pridopidine hard gelatin capsule

Outcome measures

Primary outcome
Change in Composite Unified Huntington's Disease Rating Scale (cUHDRS)
cUHDRS is a combined score to assess disease progression in HD. It includes TFC, TMS, SDMT, and SWR: Total Functional Capacity (TFC) tests the capacity to maintain daily living, finances, care level, occupation. Higher score = better outcome. Best score=13. Worst score=0. Total Motor Score (TMS) assesses motor features (oculomotor, dysarthria, chorea, dystonia, gait, postural stability). Higher score = worse outcome. Best score=0. Worst score= 124. Stroop Word Reading (SWR) measures attention and mental flexibility. Participant reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome. Best score=100. Worst score=0. Symbol Digit Modalities Test (SDMT) tests psychomotor speed and working memory. Participant has 90 sec to match numbers with symbols. Scores = correct answers in 90 sec. Higher score = better outcome. Best score=120. Worst score=0. Total integrated cUHDRS scale range: -7.6 to 24.8. The higher, the better.
Time frame Change from Baseline to Week 52
Secondary outcome
Change in Total Functional Capacity (TFC) score
Total Functional Capacity (TFC) tests the capacity to maintain domestic chores, activities of daily living, finances, care level, and occupation. Scores from 0 - 13. Higher score = better outcome.
Time frame Change from Baseline to Week 52
Secondary outcome
Change in Quantitative Motor (Q-Motor) Finger Tapping Inter-Onset Interval (FT-IOI) mean
Quantitative (Q)-motor is a clinical assessment of fine motor skills that are crucial for daily activities. It is based on the application of pre-calibrated and temperature-controlled force transducers and 3-dimensional position sensors. Higher score = worse outcome.
Time frame Change from Baseline to Week 52
Secondary outcome
Change in Stroop Word Reading (SWR) score
Stroop Word Reading (SWR) measures attention and mental flexibility. Participant reads names of colors printed in black ink. Scores reflect correct responses in 45 sec. Higher score = better outcome.
Time frame Change from Baseline to Week 52

Dates

Dates
Start date	July 1, 2026 (actual)
Primary completion	June 1, 2028 (estimated)
Completion	June 1, 2030 (estimated)
First posted	May 27, 2026 (actual)
Last updated	September 17, 2026
Results posted	Not stated in the registry record
Status last verified	May 2026

Actual means the event happened. Estimated means the sponsor expects it. The two mean different things.

Locations

5 sites are recruiting

Belgium

Belgium
Facility	City	State or region	Status
Hopital Erasme	Anderlecht		Not yet recruiting
Cliniques Universitaires Saint-Luc	Woluwe-Saint-Lambert		Not yet recruiting

Canada

Canada
Facility	City	State or region	Status
University of Calgary	Calgary	Alberta	Not yet recruiting
University of Alberta	Edmonton	Alberta	Not yet recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)	Montreal	Quebec	Not yet recruiting
North York General Hospital	Toronto	Ontario	Not yet recruiting
University of British Columbia	Vancouver	British Columbia	Not yet recruiting

Czechia

Czechia
Facility	City	State or region	Status
Vseobecna Fakultni Nemocnice V Praze	Prague		Not yet recruiting

France

France
Facility	City	Status
Centre Hospitalier Universitaire D'Angers	Angers	Not yet recruiting
CHU Henri Mondor (APHP)	Créteil	Not yet recruiting
Centre Hospitalier Universitaire Grenoble Alpes	La Tronche	Not yet recruiting
Centre Hospitalier Regional De Marseille	Marseille	Not yet recruiting

Germany

Germany
Facility	City	Status
Universitaetsklinikum Aachen AöR	Aachen	Not yet recruiting
Katholisches Klinikum Bochum gGmbH	Bochum	Not yet recruiting
Universitätsklinikum Erlangen	Erlangen	Not yet recruiting
George-Huntington-Institut GmbH	Münster	Not yet recruiting
Isar Amper Klinikum	Taufkirchen	Not yet recruiting
Universitaetsklinikum Ulm AöR	Ulm	Not yet recruiting

Italy

Italy
Facility	City	Status
Azienda Unita Sanitaria Locale Di Bologna	Bologna	Not yet recruiting
IRCCS Istituto Auxologico Italiano	Milan	Not yet recruiting
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Not yet recruiting
Azienda Ospedale Università di Padova	Padova	Not yet recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Not yet recruiting
Casa Sollievo Della Sofferenza	San Giovanni Rotondo	Not yet recruiting

Netherlands

Netherlands
Facility	City	State or region	Status
Leids Universitair Medisch Centrum (LUMC)	Leiden		Not yet recruiting

Poland

Poland
Facility	City	State or region	Status
Krakowska Akademia Neurologii Sp. z o.o.	Krakow		Not yet recruiting
Wojskowy Instytut Medycyny Lotniczej	Warsaw		Not yet recruiting

Portugal

Portugal
Facility	City	Status
Unidade Local De Saude De Coimbra E.P.E	Coimbra	Not yet recruiting
Unidade Local De Saude De Santa Maria E.P.E.	Lisbon	Not yet recruiting
Unidade Local De Saude De Santo Antonio E.P.E.	Porto	Not yet recruiting
CNS Saude Lda.	Torres Vedras	Not yet recruiting

Spain

Spain
Facility	City	Status
Hospital Universitario De Cruces	Barakaldo	Not yet recruiting
Hospital De La Santa Creu I Sant Pau	Barcelona	Not yet recruiting
Hospital Universitario Ramon Y Cajal	Madrid	Not yet recruiting
Hospital Universitario Central De Asturias	Oviedo	Not yet recruiting
Hospital Universitario Virgen del Rocío	Seville	Not yet recruiting

United Kingdom

United Kingdom
Facility	City	Status
NHS Grampian	Aberdeen	Not yet recruiting
Birmingham and Solihull Mental Health Foundation NHS Trust	Birmingham	Not yet recruiting
Cardiff University	Cardiff	Not yet recruiting
The Walton Centre NHS Foundation Trust	Liverpool	Not yet recruiting
CNTW NHS Foundation Trust	Newcastle upon Tyne	Not yet recruiting

United States

United States
Facility	City	State or region	Status
Johns Hopkins University	Baltimore	Maryland	Not yet recruiting
The University of Alabama at Birmingham	Birmingham	Alabama	Not yet recruiting
University of Miami-U Health Boca Raton	Boca Raton	Florida	Not yet recruiting
University of Vermont Medical Center	Burlington	Vermont	Not yet recruiting
Massachusetts General Hospital	Charlestown	Massachusetts	Not yet recruiting
Rush University Medical Center	Chicago	Illinois	Not yet recruiting
Northwestern University	Chicago	Illinois	Not yet recruiting
University of Cincinnati	Cincinnati	Ohio	Not yet recruiting
Cleveland Clinic	Cleveland	Ohio	Not yet recruiting

16 further sites are listed in the registry record.

Study documents

No documents are linked in this registry record.

Changes over time

August 7, 2026
Status changed
Status changed from Not yet recruiting to Recruiting
NOT_YET_RECRUITINGRECRUITING
August 7, 2026
Recruitment opened
Recruitment opened
NOT_YET_RECRUITINGRECRUITING
August 7, 2026
Site added
66 sites added (66 total)
066

Registry: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07609108

Categories

Registered in 1 registry

Interested in this study?

How this study is set up

Summary

Conditions

Eligibility

Eligibility as written in the registry

Eligibility in plain statements

Study design

Sponsor and collaborators

Arms and interventions

Interventions

Outcome measures

Dates

Locations

Belgium

Canada

Czechia

France

Germany

Italy

Netherlands

Poland

Portugal

Spain

United Kingdom

United States

Study documents

Changes over time